MIECC vs Conventional Cardiopulmonary Bypass and Systemic Inflammation in CABG
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-70
SponsorBursa Yuksek Ihtisas Training and Research Hospital
About this trial
This prospective observational study evaluates the effects of minimally invasive extracorporeal circulation (MIECC) and conventional cardiopulmonary bypass on systemic inflammatory response in patients undergoing coronary artery bypass graft surgery. Adult patients undergoing elective coronary artery bypass surgery will be observed according to the extracorporeal circulation technique used during surgery. Systemic inflammation will be assessed using routinely available hematologic inflammatory indices, including the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII). These parameters will be evaluated preoperatively, at postoperative 6 hours, at postoperative 24 hours, and at hospital discharge. The study will also evaluate selected perioperative and postoperative clinical outcomes in order to compare the inflammatory response associated with MIECC and conventional extracorporeal circulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 30-70 years
Patients undergoing elective coronary artery bypass graft surgery
Patients in whom cardiopulmonary bypass is planned
Written informed consent obtained
Disqualifiers
Emergency surgery
Redo cardiac surgery
Concomitant valve surgery
Previous open heart surgery
Trial population
Adult patients aged 30-70 years undergoing elective coronary artery bypass graft surgery with either minimally invasive extracorporeal circulation or conventional cardiopulmonary bypass at Bursa Yuksek Ihtisas Training and Research Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Minimally Invasive Extracorporeal Circulation
Procedure/SurgeryUse of a minimally invasive extracorporeal circulation system during coronary artery bypass graft surgery as part of routine clinical care.
Conventional Cardiopulmonary Bypass
Procedure/SurgeryUse of conventional cardiopulmonary bypass during coronary artery bypass graft surgery as part of routine clinical care.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: MIECC Group1 intervention
Group B: Conventional Cardiopulmonary Bypass Group1 intervention
Trial outcomes
Primary outcomes
1
Neutrophil-to-Lymphocyte Ratio (NLR)
NLR will be calculated from routine complete blood count values by dividing the absolute neutrophil count by the absolute lymphocyte count. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
Time frame
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.2
Platelet-to-Lymphocyte Ratio (PLR)
PLR will be calculated from routine complete blood count values by dividing the platelet count by the absolute lymphocyte count. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
Time frame
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.3
Systemic Immune-Inflammation Index (SII)
SII will be calculated as neutrophil count × platelet count / lymphocyte count using routine complete blood count values. Values will be compared between the MIECC and conventional cardiopulmonary bypass groups.
Time frame
Preoperative baseline, 6 hours after surgery, 24 hours after surgery, and on the morning of hospital discharge, an average of 6 days after surgery.Sponsors and contacts
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Source ClinicalTrials.gov